MAUDE Adverse Event Report: EEZCARE MEDICAL CORP. MERIDIAN; 8" APM SYSTEM

Model Number 4800

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Head Injury (1879)

Event Type  Injury  

Event Description

The end-user fell out of bed sustaining a head injury and had to be transported by ambulance.The end-user received stitches.Bed rails were not in use when the patient fell.No visible defect with the air mattress.

Event Description

Customer returned a different serial number and different item of reported device.Serial number (b)(4) and item 4800 was returned for inspection.Inspector did not realize it was a different item/different serial number at time of report.Customer initially reported serial number (b)(4) and item mer-4500 in email, sent in a picture of serial number (b)(4), and returned serial number (b)(4) and item 4800.

• Brand Name: MERIDIAN
• Type of Device: 8" APM SYSTEM
• Manufacturer (Section D): EEZCARE MEDICAL CORP.; no. 3-1, minquan street; tu-cheng district; new taipei city taipe, 23679 ; TW 23679
• MDR Report Key: 7530357
• MDR Text Key: 108798096
• Report Number: 3012316249-2018-00028
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4800
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 05/21/2018
• Distributor Facility Aware Date: 05/01/2018
• Device Age: 9 MO
• Date Report to Manufacturer: 05/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 80 YR